MyelinWatch EL
← Back to updates
Emerging treatmentsResults from peopleFDA application accepted for Priority Review, according to Roche

US new drug application accepted for FDA Priority Review, according to Roche

Fenebrutinib: Roche says FDA accepted MS application for priority review

Published by MyelinWatch:

Organisation
Roche
Study sponsor
F. Hoffmann-La Roche Ltd

What happened

On 30 September 2026, Roche announced that the US FDA had accepted its new drug application for investigational fenebrutinib, an oral BTK inhibitor, for relapsing and primary progressive multiple sclerosis under Priority Review. The application draws on three Phase 3 studies. Roche reported annualised relapse rates 51.1% and 58.5% lower than with teriflunomide in FENhance 1 and 2 over 96 weeks. In FENtrepid, fenebrutinib met the prespecified noninferiority comparison with ocrelizumab for disability progression: it was not worse by more than the study's pre-set margin. The reported hazard ratio was 0.88 (95% confidence interval 0.75–1.03).

What this means for people with MS

Acceptance for Priority Review starts an FDA assessment; it is not approval or evidence that fenebrutinib is available to patients. The FENtrepid result establishes noninferiority in that comparison, not superiority. Roche reported more liver-enzyme elevations with fenebrutinib in FENtrepid and an imbalance in the number of deaths between treatment arms across the three trials; causes varied and these safety findings need careful assessment. The cited sources do not establish access in Greece.

About the approach studied in this programme: Fenebrutinib

Fenebrutinib is an oral inhibitor of Bruton’s tyrosine kinase (BTK), a protein involved in B-cell and other immune-cell signalling. Researchers test whether altering this signalling can limit MS activity and disability progression; the mechanism does not itself establish clinical benefit or myelin repair.

Approach source: Roche — fenebrutinib development announcement ↗

What kind of evidence exists?
Roche announcement of a regulatory filing step, with sponsor-reported Phase 3 results
How reliable is this source?
Roche official announcement of its FDA filing and sponsor-reported Phase 3 results; FDA acceptance is attributed to Roche, not independently confirmed in an FDA decision record

Related study or programme: Fenebrutinib →

Understand the BTK treatment family →

Source: Roche — official company announcement ↗Source: Roche — FENhance 1 and 2 relapsing MS results and safety ↗ Source: Roche — FENtrepid primary progressive MS noninferiority results and safety ↗ Source: ClinicalTrials.gov — FENhance 1 (NCT04586010) ↗ Source: ClinicalTrials.gov — FENhance 2 (NCT04586023) ↗ Source: ClinicalTrials.gov — FENtrepid (NCT04544449) ↗
Research event/source date
Published by MyelinWatch
Last substantive MyelinWatch update

Related substantive developments

Research event/source date:
Emerging treatmentsRegistered study in peopleStudy authorised in Greece; not a result

Phase 3 extension study authorised in Greece; recruitment not yet started

Frexalimab: Greece authorises the long-term Phase 3 extension study

Organisation: Sanofi · France

The EU Clinical Trials Information System (CTIS) shows that Greece authorised Sanofi's Phase 3 extension study LTS18002 (2026-525688-41-00) on 2 November 2026. Denmark, Portugal and Poland authorised it on the same day, after Belgium (30 October 2026) and Austria (1 November 2026); all six countries are listed as authorised with recruitment pending. The record plans 17 participants in Greece and lists four Greek hospitals: AHEPA University General Hospital of Thessaloniki, the University General Hospital of Ioannina, the General University Hospital of Larissa and the 401 General Military Hospital of Athens. The study will look at the long-term safety and tolerability of frexalimab, an experimental antibody, in people with multiple sclerosis (MS). It is open only to people who complete earlier frexalimab studies on the study drug, such as the Phase 3 studies FREXALT and FREVIVA. The estimated EU recruitment start is 15 February 2027.

Published by MyelinWatch:

What this means for people with MS

Authorisation means the study may proceed in Greece; it does not mean that it has started at any Greek hospital, that anyone has received treatment in it, or that frexalimab works. No Phase 3 results are available yet. People who are not already in a frexalimab study cannot join this extension, so it is not a way for other people with MS in Greece to receive frexalimab. Frexalimab is not an available treatment in Greece.

Read the update →Source: EU Clinical Trials Information System (CTIS), European Medicines Agency — official CTIS record ↗Source: ClinicalTrials.gov — FREXALT (NCT06141473), Phase 3, ongoing, not accepting new participants ↗ Source: ClinicalTrials.gov — FREVIVA (NCT06141486), Phase 3, ongoing, not accepting new participants ↗
Research event/source date:
Emerging treatmentsRegistered study in peopleStudy authorised in two EU countries; not a result

Phase 3 extension study authorised in two EU countries; recruitment not yet started

Frexalimab: long-term Phase 3 extension study authorised in Belgium and Austria

Organisation: Sanofi · France

The EU Clinical Trials Information System (CTIS) shows that Belgium authorised Sanofi's Phase 3 extension study LTS18002 (2026-525688-41-00) on 30 October 2026 and Austria on 1 November 2026. The study will look at the long-term safety and tolerability of frexalimab, an experimental antibody given into a vein or under the skin, in people with multiple sclerosis (MS). It is open only to people with relapsing MS or non-relapsing secondary progressive MS who complete earlier frexalimab studies on the study drug, including the Phase 3 studies FREXALT and FREVIVA. It plans 1,710 participants in total. Both countries are listed as authorised with recruitment pending; the estimated EU recruitment start is 15 February 2027.

Published by MyelinWatch:

What this means for people with MS

Authorisation means the study may proceed; it does not mean that it has started, that anyone has received treatment in it, or that frexalimab works. No Phase 3 results are available yet. People who are not already in a frexalimab study cannot join this extension. Greece authorised the study later, on 2 November 2026 (see the separate update); frexalimab is not an available treatment in Greece.

Read the update →Source: EU Clinical Trials Information System (CTIS), European Medicines Agency — official CTIS record ↗Source: ClinicalTrials.gov — FREXALT (NCT06141473), Phase 3, ongoing, not accepting new participants ↗ Source: ClinicalTrials.gov — FREVIVA (NCT06141486), Phase 3, ongoing, not accepting new participants ↗
Research event/source date:
Emerging treatmentsResults from peopleSubgroup finding: significant in Hispanic or Latino participants, not significant in Black participants

Post hoc analysis of two completed Phase 3 trials in relapsing MS

OPERA trials: post hoc look at disability worsening in Black and Hispanic or Latino participants

Organisation: Keck School of Medicine, University of Southern California, with Genentech and Roche · United States

Researchers led by the University of Southern California, with authors from Genentech, Roche and other US centres, re-analysed the OPERA I and II trials, which compared ocrelizumab with interferon beta-1a for two years in relapsing multiple sclerosis (MS). In the interferon group, non-Hispanic Black and Hispanic or Latino participants had a higher risk of disability worsening confirmed after 24 weeks, measured with a combined (composite) disability measure, than non-Hispanic White participants (hazard ratio 3.0 and 2.3). Non-Hispanic Black and Hispanic or Latino participants also had more CD19-positive B cells at the start. In 1,138 participants who consented to genetic analysis, higher African or Americas genetic ancestry was also linked to higher risk. Ocrelizumab lowered B cells in all groups. Compared with interferon, it lowered the risk of this composite disability worsening in Hispanic or Latino participants (hazard ratio 0.38; 95% confidence interval 0.20–0.72). In the 65 Black participants the estimate also pointed to lower risk (hazard ratio 0.41), but the 95% confidence interval of 0.13–1.29 includes no difference, so the result is not statistically significant.

Published by MyelinWatch:

What this means for people with MS

This is not a new treatment or a new approval: ocrelizumab is already an approved MS treatment. The analysis was done after the trials ended, in small subgroups (only 65 Black participants), using self-reported race and ethnicity; it cannot show why risk differed and does not change treatment guidance. The authors conclude that ocrelizumab reduced risk regardless of race or ethnicity, but for Black participants the study alone does not establish this. It does not establish availability or reimbursement in Greece or support changing an individual treatment without a neurologist.

Read the update →Source: Multiple Sclerosis Journal (SAGE) — peer-reviewed primary article ↗Source: Multiple Sclerosis Journal — DOI 10.1177/13524585261496124 ↗ Source: ClinicalTrials.gov — OPERA I (NCT01247324), completed with posted results ↗ Source: ClinicalTrials.gov — OPERA II (NCT01412333), completed with posted results ↗